Senior System Verification Engineer (Medical Device)

Neko Health

Stockholm, Sweden

We're looking for a Senior System Verification Engineer to join our multidisciplinary engineering team. You'll take ownership of system-level verification across the product lifecycle, from early concept through industrialization and market release. Working closely with hardware, firmware, and software teams, you'll turn standards and regulatory requirements into testable requirements and verification strategies that stand up to safety, performance, and regulatory scrutiny.

Responsibilities

Own the system-level verification strategy for our device hardware, from concept through industrialization and market release, with the IEC 60601 series as the frame;
Write verification protocols against a controlled requirement baseline, run them, and sign the report, documenting results, defects, and compliance status for the teams that need them;
Shape product requirements early with cross-functional teams so they're testable, traceable, and carry their compliance needs on the face of them, and keep the traceability matrices that prove every requirement has verification behind it;
Verify against in-development firmware and software builds, not only finished ones;
Develop verification methods, tools, and workflows for end-to-end, integration, and regression testing, with automation where it removes repeat effort or human error, and improve how we verify as the product grows;
Coordinate specialized testing with external test houses (EMC, electrical safety, environmental), owning the interface between our internal requirements and their verification activities;
Carry test requirements through design transfer, so quality, safety, and compliance hold as products move from development into manufacturing.

Requirements

Must have:

5+ years in system verification and validation of medical devices;
Experience with complex embedded systems (hardware, firmware, software) and system-level testing such as EMC, electrical safety, and environmental testing;
IEC 60601-1 and IEC 60601-1-2 applied on real products, with a track record of turning a clause into a verification strategy;
Hands-on experience developing and executing both manual and automated test methods;
Comfortable working across hardware, firmware, software, quality, regulatory, and external partner teams;
Bachelor's or Master's degree in engineering or a related technical field;
Documentation another engineer can follow: protocols and reports that hold up without you in the room. Professional English.